Associate Director, Regulatory Advertising Promotion (Remote)

Key Duties and Responsibilities: • Provides specialized knowledge on region/country regulations and requirements governing product promotion and related communications, including pipeline and disease state communications • Serves as regulatory reviewer for assigned product(s) on Communications Review Committee (CRC) and Medical Review Committee (MRC), and as Regulatory CoRA representative on program and other cross-functional teams • May serve as Chair of CRC for assigned product(s) and therapeutic area(s), leading discussions between Regulatory, Legal, Medical, Commercial and other stakeholders to reach consensus CRC decisions • In collaboration with Medical, Legal and Commercial, provides regulatory leadership to ensure that regulatory requirements are integrated in product and disease-state communications • As a regulatory reviewer, assesses the regulatory context and provide regulatory interpretations of applicable guidance and/or regulations or regulatory precedents, including requirements related to submission of material to Health Authority (HA) and interact with HA, as applicable • Provides guidance and input for development products reflective of promotional considerations • Provides direction and work collaboratively to ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements • Collaborates in cross-functional efforts to develop and update procedures and guidelines related to CRC processes • Monitors and interprets advertising and promotion regulations and guidelines to support successful and compliant marketing of Vertex products and assess impact • Plans and conducts training sessions as needed with stakeholders Knowledge and Skills: • Thorough knowledge of applicable Health Authority codes, laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments • In-depth understanding of clinical study design and statistical analyses in assessment of promotional claims • Strong interpersonal and communication skills communicate difficult concepts and persuade others • Ability to innovate, analyze, and solve problems • Pharmaceutical industry and regulatory ad/promo experience, including interacting with health authorities In this Remote, Hybrid, or On-Site-Eligible role, you canchoose to work: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. Company Information